BEUDAMED
    FDA Adverse Event Death Summary report: N

    GAMMA

    MDR report key: 3760688 · Received April 10, 2014

    Report

    Report Number
    1220063-2014-00013
    Event Type
    Death
    Date Received
    April 10, 2014
    Date of Event
    March 28, 2014
    Report Date
    March 28, 2014
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    MHX
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DRAEGER IS STILL INVESTIGATING THE REPORTED INCIDENT. A FOLLOW-UP REPORT WILL BE SUBMITTED AS SOON AS THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ACCORDING TO THE CUSTOMER, THE PT WAS MONITORED WITH THE ABOVE MENTIONED PT MONITOR WHILE AN EVENT OCCURRED AT AROUND 06:10 AM, DURING WHICH THE PT EXPIRED. THE CUSTOMER REPORTED THAT THE PT WAS BEING MONITORED FOR THE ENTIRE NIGHT AND ALL DATA WAS AVAILABLE AT THE CENTRAL. THE DATABASE OF THE OLD MVWS (MULTIVIEW WORKSTATION) DOES NOT CONTAIN ANY DATA FOR THE TIME BETWEEN (B)(6) 2009:54:32 AM UNTIL (B)(6) 06:16:16:08 AM. ALSO, THE PT MONITOR DOES NOT CONTAIN ANY TREND DATA. AT THE TIME I ARRIVE ALL ALARMS WERE DISABLED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216191 GAMMA PATIENT MONITOR MHX DRAEGER MEDICAL SYSTEMS, INC. UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death NO